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510(k) K812050

KALLESTAD ANTISERA TO GENTAMICIN by Kallestad Laboratories, Inc. — Product Code DJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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